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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Over-The-Counter
510(k) Number K073220
Device Name THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT
Applicant
Prestige Brands, Inc.
90 N Broadway
Irvington,  NY  10533
Applicant Contact KAREN A COSTA-STRACHAN
Correspondent
Prestige Brands, Inc.
90 N Broadway
Irvington,  NY  10533
Correspondent Contact KAREN A COSTA-STRACHAN
Classification Product Code
OBR  
Date Received11/15/2007
Decision Date 12/19/2007
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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